Spinal Injury Project

Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial

In partnership with

What is the Spinal Injury Project?

What if the ability to repair a spinal cord injury became a reality in the next five years? The Spinal Injury Project at Griffith University, in partnership with the Perry Cross Spinal Research Foundation, is on the cusp of making this happen with a world-first Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial. The Spinal Injury Project is part of the Clem Jones Centre for Neurobiology and Stem Cell Research and is directed by Professor James St John.

The Spinal Injury Project has a team of internationally recognised researchers based in state-of-the-art laboratories at the Gold Coast and Nathan campuses of Griffith University.

The project team is a leading group of research specialists including bioengineers, medical doctors, biological scientists and educators working together to develop this breakthrough treatment. The research was first initiated by the late Griffith University Professor Emeritus, and 2017 Australian of the Year, Alan Mackay-Sim almost 20 years ago. He was a pioneer in stem cell research and was successful in taking cells from the olfactory (nasal) system, transplanting them to the injury site and demonstrating that it was safe for use in humans.

Building on Professor Mackay-Sim’s incredible legacy, the ongoing research at Griffith University has made considerable improvements by developing a nerve bridge which improves how the cells are transplanted. The team has shown that the nerve bridges can repair spinal cord injury in preclinical work, and the clinical trial hopes to show that the nerve bridges can repair spinal cord injuries in humans.

The Spinal Injury Project is translating a comprehensive cell transplantation therapy with an exercise-based rehabilitation therapy to treat traumatic spinal cord injury.

This world-first treatment for spinal cord injury uses specialised cells from within the nose. The cells are called olfactory ensheathing cells (OECs) and they can work in numerous different ways to stimulate repair of nerves.

The olfactory cells are purified from a simple biopsy taken from within the nose, a cellular nerve bridge of OECs is manufactured for transplantation into the injured spinal cord, where the special regenerative capacity of transplanted OECs stimulates spinal cord regeneration.

The therapy has been developed over the last 10years by a large team at the Clem Jones Centre for Neurobiology and Stem Cell Research, Griffith University in Queensland. The diverse team has over 40 translational biomedical researchers who come from 19 different countries. In addition to the lab members, the team also works with many external specialist researchers, clinicians and allied health professionals to drive the therapy to clinical trial.

The Treatment

This ground-breaking, world-first treatment involves the transplantation of the patient’s own olfactory cells from the nose into the spinal cord. The cells are formulated into nerve bridges which are transplanted directly into the injury site. To help stimulate regeneration and to reinforce connections that are made, intensive rehabilitation takes place before and after the cell transplantation.

The human clinical trial is anticipated to start in 2025 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have thirty participants, twenty who will undergo the nerve bridge transplantation and rehabilitation program and ten participants who do only the rehabilitation program.

The Cost

Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.

Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.

The Spinal Injury Project is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification and engineering techniques the team has designed three-dimensional nerve bridges that allow neurosurgeons to precisely place the cells into the injury site. This dramatically improves the survival of the cells.

By enabling the cells to form stable connections within the nerve bridge prior to transplantation, the cells rapidly form a permissive bridge over the injury site that allows the spinal cord nerve cells to regenerate. Using the patient’s own cells greatly improves the safety of the treatment. This results in a treatment that has extremely rapid production times, is more effective and more affordable.

The Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial is a truly inspirational endeavour. Through generous supporters like you, our funding partners, philanthropists, and our incredible fundraising community, we have raised the $8.5M needed to commence the trial for 15 people. This includes a $2M contribution from Queensland Health and $1M from Nicola and Andrew Forrest.

Professor James St John and his team were awarded a Medical Research Future Fund 2023 Stem Cell Therapies Grant of $6.8M for the clinical trial. With this funding award, the clinical trial will now be open for thirty participants living with a spinal cord injury.

What is the current status of the Spinal Injury Project Trial?

The good news is that we are on track to commence the trial in 2025, subject to the relevant approvals being in place.

The past year has been dedicated to intensive preparation for the Phase I cell therapy and rehabilitation clinical trial, scheduled to commence recruitment in 2025. A key milestone was the appointment of a Contract Research Organisation (CRO), Accelagen Pty Ltd. This involved a rigorous selection process, including a limited tender and careful evaluation of potential companies based on attention to detail, corporate social responsibility, and cost-effectiveness. Contract negotiations, while extensive, successfully concluded with the signing of a master services agreement in early September.

With this crucial partnership established, we are now actively working with the CRO to advance the development of the clinical trial set up. Simultaneously, we are engaging with external stakeholders and vendors such as the rehabilitation providers and companies who will play vital roles in data collection, such as those providing blood tests and radiology services.

Significant progress has also been made on the regulatory front. Ethics applications, protocols and investigator’s brochures have been meticulously prepared and have received approval from the hospital’s HREC committee. The trial has also been registered on the Australian New Zealand Clinical Trials Registry. Finally, we are currently awaiting the final green light from the hospital’s research governance organisation. Once this approval is granted, official recruitment for the trial will begin.

To de-risk the trial, the Foundation with the support of our incredible donors, has already funded two rehabilitation clinical trials run by Griffith University and purchased an advanced microscope for the safety testing of the cells in preparation for the trial.

The first rehabilitation trial involved people who had previous experience with rehabilitation programs but not at the intensity that is needed for the trial. The outcomes showed that the intensive long-term rehabilitation program is safe and that participants enjoyed the program and peer support. The Foundation fully funded this rehabilitation trial at a cost of $450,000 for five participants – read more below.

The second rehabilitation trial showed that people with little experience with intensive rehabilitation were also able to safely complete the program and they too enjoyed the peer support and experience. Together these trials provided confidence that intensive long-term rehabilitation is suitable for people living with chronic spinal cord injury. The Foundation fully funded this second rehabilitation trial at a cost of $420,000 for five participants – read more below

Safety is a priority for the trial and for this reason the Foundation funded the LiveCyte microscope for the research team. This microscope uses live-cell imaging to track the fate of all cells that are being viewed. This allows the researchers to confirm that the cells are behaving in the appropriate way and that there are no undesirable cells within the population. This new technology provides an incredible advance for cell transplantation therapies and to have it as part of the trial is of immense importance for safety screening. The livecyte microscope was funded in full by the Foundation through the support of our donors at a cost of $400,000 – read more below

The Treatment

The human clinical trial is anticipated to start in 2024 and aims to test the safety and efficacy of the nerve bridge transplantation and rehabilitation. The trial will have fifteen participants, ten who will undergo the nerve bridge transplantation and rehabilitation program and five participants who do only the rehabilitation program.

The Cost

Participants will train intensively at a rehabilitation provider for 3 months at the start of the trial, and then 8 months at the end.

Throughout the trial functional, medical and psychological assessments will be conducted to determine the outcomes for each participant.

The cost to run this trial for fifteen participants is $8.5M. The Nerve Bridge Transplantation and Rehabilitation Human Clinical Trial is a truly inspirational endeavour. Through generous

supporters like you, our funding partners, philanthropists, and our incredible fundraising community, we have raised $7.6M of the funding needed to commence the trial.

The Foundation and Griffith University will continue to work together to fundraise to ensure the funding required is raised in full.

What is the current status of the Spinal Injurt Project Trial?

The good news is that we are on track to commence the trial in mid-2024, subject to the relevant approvals being in place. The first approval is the human ethics which considers the safety and benefits of the treatment. The second approval is research governance which ensures that the medical safety team is appointed, contracts with all the providers and partners are in place, and that funding and insurance are available. Once the approvals are obtained, then advertising and recruitment will commence.

Thanks to the generous donations from the community and partner organisations including; Queensland Health, Nicola and Andrew Forrest, the Clem Jones Foundation, Brazil Family Foundation, Rhonda and Terry White and Griffith University, we have funding to proceed with the original plan to have fifteen people recruited to the trial, ten for the nerve bridge transplantation and rehabilitation program, plus five controls who will do just the rehabilitation program.

The Spinal Injury Project team is also seeking additional funding from various government and international funding agencies to expand the trial to 30 participants, but the outcomes are uncertain and won’t be known for many months. For this reason, the team has decided to commence the trial for the fifteen participants with the funding that has been raised so far.

The first rehabilitation trial involved people who had previous experience with rehabilitation programs but not at the intensity that is needed for the trial. The outcomes showed that the intensive long-term rehabilitation program is safe and that participants enjoyed the program and peer support. The Foundation fully funded this rehabilitation trial at a cost of $450,000 for five participants – you can read more here. (https://perrycrossspin.wpenginepowered.com/intensive-rehabilitation-trial-1-results/)
The second rehabilitation trial showed that people with little experience with intensive rehabilitation were also able to safely complete the program and they too enjoyed the peer support and experience. Together these trials provided confidence that intensive long-term rehabilitation is suitable for people living with chronic spinal cord injury. The Foundation fully funded this second rehabilitation trial at a cost of $420,000 for five participants – you can read more here. https://perrycrossspin.wpenginepowered.com/intensive-prehabilitation-trial-is-underway/
Safety is a priority for the trial and for this reason the Foundation funded the LiveCyte microscope for the research team. This microscope uses live-cell imaging to track the fate of all cells that are being viewed. This allows the researchers to confirm that the cells are behaving in the appropriate way and that there are no undesirable cells within the population. This new technology provides an incredible advance for cell transplantation therapies and to have it as part of the trial is of immense importance for safety screening. The livecyte microscope was funded in full by the Foundation through the support of our donors at a cost of $400,000 – you can read more here. (https://perrycrossspin.wpenginepowered.com/cutting-edge-microscope-to-help-find-a-cure-for-paralysis/)

What is the Spinal Injury Project?

The Spinal Injury Project is in pursuit of a cure and is working with a laser focus towards the ultimate goal – a Human Clinical Trial.

This ground-breaking, world first project involves the transplantation of the patient’s own olfactory ensheathing cells (OECs) from the nose into the spinal cord. This experimental treatment has shown promise in previous human clinical trials and now needs further refinement.

The SIP team is reinventing and rethinking how cells can grow leading to the creation of new cell products. By combining advanced cell purification techniques and engineering, the team is designing three-dimensional nerve bridges that will help regenerate the spinal cord.

These 3D cell constructs use newly invented, award winning technology involving 3D printed templates. This methodology ensures patients receive optimal restoration of motor and sensory function and outcomes are as consistent as possible.

This approach has recently been successfully tested in pre-clinical models and has shown promising functional outcomes. This incredible approach has the potential to result in the first widely available treatment for spinal cord injury and it is being developed here in Australia.

Institution:Griffith University
Lead Researcher:Prof James St John
PCSRF funding period:2023 - 2026
Total Funds Committed:$300,000

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Griffith University Fellowship – Dr Mo Chen

Institution:Griffith University
Lead Researcher:Prof James St John
PCSRF funding period:2023 - 2025
Total Funds Committed:$149,000

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LiveCyte Microscope

Institution:Griffith University
Lead Researcher:Prof James St John
PCSRF funding period:2023 - Ongoing
Total Funds Committed:$400,000

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Contract Research Organisation Scoping

Institution:Griffith University
Lead Researcher:Prof James St John
PCSRF funding period:2023 - 2024
Total Funds Committed:$88,000

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$5.4M funding injection from MAIC

Institution:Griffith University
Lead Researcher:Prof James St John
PCSRF funding period:2023 - 2026
Total Funds Committed:$5,400,000

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Cleaning Up the Injury Site

Institution:Griffith University
Lead Researcher:Assoc Prof. Jenny Ekberg
PCSRF funding period:2018 – 2022 (Ongoing)
Total Funds Committed:$430,252

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Are you interested in participating in the clinical trial?

Thank you for your interest in supporting the Perry Cross Spinal Research Foundation and the Spinal Injury Project at Griffith University and participating in this ground-breaking trial.

To learn more on the status of the trial, the current criteria to participate and to register your interest please visit the Griffith University website. The webpage will be updated with an Expression of Interest link once recruitment begins. You can also email scitrial@griffith.edu.au with any questions.

Once news becomes available about the trial, we will email the database to advise them of the next steps. The recruitment will all be done independently from the Foundation and conducted by Griffith University who will host the Expression of Interest Application.

Please click here to register your interest.

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